Stents and related methods

ABSTRACT

Stents are disclosed herein. In some embodiments stents within the scope of this disclosure may comprise a first flared end and second flared end. In some embodiments, a profile of each of the first flared end and the second flared end may circumscribe a portion of separate elliptical arcs. In some embodiments, the stents are formed from braided or woven wires having a constant pitch along a middle region and continuously varying pitches along the first flared end and the second flared end. Methods of manufacturing stents are disclosed herein. Methods of using stents are also disclosed herein.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/994,260 filed Aug. 14, 2020, and titled “Stents and Related Methods,”which is a continuation of U.S. patent application No. 15/921,172 filedMar. 14, 2018, and titled “Transluminal Stents and Related Methods,”which claims priority to U.S. Provisional Application No. 62/471,746filed Mar. 15, 2017, and titled “Transluminal Stents and RelatedMethods,” each of which is hereby incorporated by reference in itsentirety.

TECHNICAL FIELD

This application generally relates to medical devices. Moreparticularly, this application relates to stents and related methods.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 illustrates an exemplary embodiment of a stent in an unelongatedand unstretched state, such as when in use in vivo.

FIG. 2 illustrates the exemplary embodiment of FIG. 1 in an elongatedand stretched state, such as when loaded in a stent pod of a deliverycatheter prior to deployment in vivo.

FIG. 3 illustrates the shape of the exemplary embodiment of FIG. 1 .

FIG. 4 illustrates the shape of an additional exemplary embodiment.

FIG. 5 illustrates braid angles and wire pitches for the exemplaryembodiment of FIG. 1 .

FIG. 5A is a close-up view of the braid pattern of the middle region ofthe exemplary embodiment of FIG. 1 .

FIG. 5B illustrates various pitches of different regions of the stent.

FIG. 6 illustrates one embodiment for forming wire end loops and joiningwires for the exemplary embodiment of FIG. 1 .

FIG. 6A illustrates an embodiment of braided or woven wires starting andterminating in a middle region of a stent.

FIG. 7 illustrates an exemplary embodiment similar to the embodiment ofFIG. 1 , but with staggered end loops.

FIG. 8 illustrates an exemplary embodiment of a mandrel for use inmanufacturing the exemplary embodiment of FIG. 1 .

DETAILED DESCRIPTION

Stents are disclosed herein. In some embodiments, the stents describedherein comprise a hollow cylindrical body having an interior dimensionand an exterior dimension and comprising a middle region that extends toa first flared end and also extends to an opposing second flared end.The interior dimension refers to the three dimensional space within thestent, while the exterior dimension refers to the space outside of thestent. As used herein, the hollow cylindrical body may refer togenerally cylindrical shapes and forms, including stents with flaredends, for example.

The first flared end may comprise a first inner shoulder, a first crest,a first outer taper, and a first opening. The first inner shoulder mayextend from one end of the middle region to the first crest. A diameterof the first crest may be greater than a diameter of the middle region.The first outer shoulder may extend from the first crest to the firstopening. The first opening may provide a first boundary between theinterior dimension and the exterior dimension.

Likewise, the second flared end may comprise a second inner shoulder, asecond crest, a second outer taper, and a second opening. The secondinner shoulder may extend from one end of the middle region to thesecond crest. The diameter of the second crest may be greater than adiameter of the middle region. The second outer shoulder may extend fromthe second crest to the second opening. The second opening may provide asecond boundary between the interior dimension and the exteriordimension.

In some embodiments, the hollow cylindrical body may be characterized bya longitudinal plane that bisects the hollow cylindrical body along itslongitudinal axis, may be characterized by a first perpendicular planethat encompasses a circle defined by the first crest, and may becharacterized by a second perpendicular plane that encompasses a circledefined by the second crest, where the first and second perpendicularplanes are perpendicular to the longitudinal plane. In such embodiments,a profile of at least a portion of the first inner shoulder, the firstcrest, and at least a portion of the first outer taper may circumscribea portion of a first elliptical arc of a first ellipse that lies in thelongitudinal plane. The first elliptical arc may include an upperantipodal point of the first ellipse and a lower antipodal point of thefirst ellipse may be outwardly offset along the longitudinal planerelative to the first perpendicular plane and the middle region.Likewise, in such embodiments, a profile of at least a portion of thesecond inner shoulder, the second crest, and at least a portion of thesecond outer taper may circumscribe a portion of a second elliptical arcof a second ellipse that lies in the longitudinal plane. The secondelliptical arc may include an upper antipodal point of the secondellipse and a lower antipodal point of the second ellipse may beoutwardly offset along the longitudinal plane relative to the secondperpendicular plane and the middle region.

In some embodiments, the hollow cylindrical body may comprise braided orwoven wires having a constant pitch along a length of the middle region.The braided or woven wires may have a uniformly varying pitch along thefirst inner shoulder. The braided or woven wires may have a constantpitch at the first crest. The braided or woven wires may have auniformly varying pitch along the first outer taper. The braided orwoven wires may have a uniformly varying pitch along the second innershoulder. The braided or woven wires may have a constant pitch at thesecond crest. The braided or woven wires may have a uniformly varyingpitch along the second outer taper.

It will be readily understood that the components of the embodiments asgenerally described and illustrated in the figures herein could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thepresent disclosure, but is merely representative of various embodiments.While various aspects of the embodiments are presented in drawings, thedrawings are not necessarily drawn to scale unless specificallyindicated.

The phrases “communication with” and “coupled to” are used in theirordinary sense, and are broad enough to refer to any suitable couplingor other form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may interact with each other even thoughthey are not in direct contact with each other. For example, twocomponents may be coupled to each other through an intermediatecomponent. The directional terms “proximal” and “distal” are used hereinto refer to opposite locations on a component or device. The proximalend of a component or device is defined as the end of the device closestto the practitioner when the device is in normal use by thepractitioner. The distal end is the end opposite the proximal end, alongthe longitudinal direction of the device, or the end farthest from thepractitioner during normal use.

FIG. 1 illustrates an exemplary embodiment of a stent 100 in anunelongated and unstretched state, such as when in use in vivo. Stent100 comprises a hollow cylindrical body 101 having an interior dimension102 (see FIG. 3 ) and an exterior dimension 103. The hollow cylindricalbody 101 comprises a middle region 110 that extends to a first flaredend 120 and also extends to an opposing second flared end 130.

In some embodiments, the overall length of the stent 100 in theunelongated and unstretched state may range from 15 to 36 mm, includingranging from 20 to 34 mm or from 24 to 28 mm. In some embodiments, thelength of the first flared end 120 and/or the second flared end 130 inthe unelongated and unstretched state may each range from 3.5 to 8 mm,including ranging from 6 to 8 mm. In some embodiments, the length of themiddle region 110 in the unelongated and unstretched state may rangefrom 8 to 20 mm, including ranging from 10 to 16 mm.

FIG. 2 illustrates the exemplary embodiment of FIG. 1 in an elongatedand stretched state, such as when loaded in a stent pod of a deliverycatheter prior to deployment in vivo.

In some embodiments, the overall length of the stent 100 in theelongated and stretched state may range from 40 to 74 mm, includingranging from 46 to 72 mm or from 60 to 70 mm. In some embodiments, thelength of the first flared end 120 and/or the second flared end 130 inthe elongated and stretched state may each range from 15 to 23 mm,including ranging from 16 to 21 mm. In some embodiments, the length ofthe middle region 110 in the elongated and stretched state may rangefrom 15 to 23 mm, including ranging from 16 to 21 mm.

FIG. 3 illustrates the shape of the exemplary embodiment of FIG. 1 . Thefirst flared end comprises a first inner shoulder 122, a first crest124, a first outer taper 126, and a first opening 128. The first innershoulder 122 extends from a proximal end 112 of the middle region 110 tothe first crest 124. In the illustrated embodiment, the diameter of thefirst crest 124 is greater than the diameter of the middle region 110,for example, about 1.3 to about 2.9 times, such as about 1.4 to about2.9 and such as about 1.3 to about 2.0, the diameter of the middleregion 110. The first outer taper 126 extends from the first crest 124to the first opening 128. The first opening 128 provides a firstboundary between the interior dimension 102 and the exterior dimension103.

Likewise, the second flared end 130 comprises a second inner shoulder132, a second crest 134, a second outer taper 136, and a second opening138. The second inner shoulder 132 extends from the distal end 113 ofthe middle region 110 to the second crest 134. The diameter of thesecond crest 134 is greater than the diameter of the middle region 110,for example, about 1.6 to about 2.5 times the diameter of the middleregion 110. The second outer taper 136 extends from the second crest 134to the second opening 138. The second opening 138 provides a secondboundary between the interior dimension 102 and the exterior dimension103. In the illustrated embodiments, the diameter of the first opening128 is greater than the diameter of the middle region 110, but less thanthe diameter of the first crest 124. Likewise, the diameter of thesecond opening 138 is greater than the diameter of the middle region110, but less than the diameter of the second crest 134. This canfacilitate removal of the stent 100 from a mandrel 200, as will bediscussed more below in relation to FIG. 8 .

This can also reduce particle entrapment during drainage via theinterior dimension 102. Particles and fluid can tend to fill theinterior dimension 102 of the first and second flared ends 120 and 130during use, such as drainage of the gall bladder, a biliary tract, or apancreatic cyst. When the diameter of the first and second openings 128and 138 are the same diameter or smaller than the diameter of the middleregion 110, this can make removal of fluid and particles from theinterior dimension 102 of the first and second flared ends 120 and 130difficult. Increasing the diameter of the first and second openings 128and 138, relative to the diameter of the middle region 110, canfacilitate particle and fluid removal from the interior dimension 102 ofthe first and second flared ends 120 and 130.

In an alternative embodiment, the first crest 124 may form a planarregion (cylindrical region from a perspective view) parallel to themiddle region 110. In this alternative embodiment, the diameter of thefirst crest 124 could still be greater than the diameter of the middleregion 110. Likewise, the second crest 134 may form a planar regionparallel to the middle region 110.

In addition, the first opening 128 may comprise a cylindrical regionthat proximally extends the longitudinal length of the stent 100. Thefirst opening 128 would terminate at the proximal end of the cylindricalregion. The cylindrical region would be coaxial with the longitudinalaxis 104. The planar surface of the cylindrical region (from a profileview) would be parallel to the middle region 110. Likewise, the secondopening 138 may comprise a cylindrical region that distally extends thelongitudinal length of the stent 100. The second opening 138 wouldterminate at the distal end of the cylindrical region.

FIG. 3 illustrates the hollow cylindrical body 101 bisected in alongitudinal plane along its longitudinal axis 104. The hollowcylindrical body 101 is characterized by a first perpendicular plane 123that encompasses a circle defined by the first crest 124 andcharacterized by a second perpendicular plane 133 that encompasses acircle defined by the second crest 134. The first and secondperpendicular planes 123 and 133 are perpendicular to the longitudinalplane (i.e., the page). In the illustrated embodiment, a profile of atleast a portion of the first inner shoulder 122, the first crest 124,and at least a portion of the first outer taper 126 circumscribe a firstelliptical arc 142 of a first ellipse 140 that lies in the longitudinalplane. The first elliptical arc 142 includes an upper antipodal point144 and a lower antipodal point 146. The upper antipodal point 144 isinwardly inset relative to the first perpendicular plane 123 (and themiddle region 110) and the lower antipodal point 146 is outwardly offsetrelative to the first perpendicular plane 123. Likewise, in suchembodiments, a profile of at least a portion of the second innershoulder 132, the second crest 134, and at least a portion of the secondouter taper circumscribes a second elliptical arc 152 of a secondellipse 150 that lies in the longitudinal plane (i.e., the page). Thesecond elliptical arc 152 includes an upper antipodal point 154 and alower antipodal point 156 of the second ellipse. The upper antipodalpoint 154 is inwardly inset relative to the second perpendicular plane133 (and the middle region 110) and the lower antipodal point 156 isoutwardly offset relative to the second perpendicular plane 133.

For example, the lower antipodal point 146 may be outwardly offset alongthe longitudinal plane 104 relative to the first perpendicular plane 123and the major axis 145 of the first ellipse 140 by an angle θ₁ of about5 degrees to about 60 degrees, about 10 degrees to about 45 degrees,about 10 degrees to about 40 degrees, or about 10 degrees to about 25degrees. Likewise, for example, the lower antipodal point 156 may beoutwardly offset along the longitudinal plane 104 relative to the secondperpendicular plane 133 and the major axis 145 by an angle θ₂ of about−5 degrees to about −60 degrees, about −10 degrees to about −45 degrees,about −10 degrees to about −40 degrees, or about −10 degrees to about−25 degrees.

In the illustrated embodiments, the profile of the second flared end 130is a mirror image of the first flared end 120. In alternativeembodiments, the shape of the second flared end 120 may differ from theshape of the first flared end 110, in some cases, significantly.

FIG. 4 illustrates an exemplary embodiment of stent 100′ where θ₁ (asdefined by the first perpendicular plane 123′ and the major axis of thefirst ellipse 145′) and θ₂ (θ₂ not shown) are about 45 degrees and −45degrees, respectively. It should be understood that the disclosureregarding the stent 100 applies equally to the stent 100′, other than asspecifically delineated. In FIG. 4 , the first elliptical arc 142′ ofthe first ellipse 140′ circumscribes a portion of the first shoulder122′, but does not extend to the first perpendicular region 122 a′.Likewise, the first elliptical arc 142′ circumscribes a portion of thefirst outer taper 126′, but does not extend to the first opening 128′.

In the illustrated embodiments, the first inner shoulder 122 comprises afirst perpendicular region 122 a concentrically surrounding andperpendicular to the middle region 110. The first elliptical arc 142extends from the first perpendicular region 122 a, along the first crest124, and along the first outer taper 126 to the first opening 128.Likewise, the second inner shoulder 132 comprises a second perpendicularregion 132 a concentrically surrounding and perpendicular to the middleregion 110. The second elliptical arc 152 extends from the secondperpendicular region 132 a, along the second crest 134, and along thesecond outer taper 136 to the second opening 138. The first and secondperpendicular regions 122 a and 132 a facilitate retention of the firstand second inner shoulders 122 and 132 against tissue walls when thestent 100 is in use, as compared to flared ends 120 and 130 that do notinclude surfaces perpendicular to the middle region 110 in the innershoulders 122 and 132.

In contrast, in the illustrated embodiments, the first and second outertapers 126 and 136 do not include regions perpendicular to the middleregion 110. This increases stiffness of the first and second flared ends120 and 130, relative to a flared end that includes a perpendicularregion in an outer shoulder. For example, a flared end that includes asymmetrical inner shoulder and outer shoulder (i.e., mirror imageprofiles), where both the inner shoulder and the outer shoulder includeperpendicular regions, can tend to deflect more outwardly (relative tothe middle region) when in use, as compared to embodiments such as theillustrated embodiments where the inner shoulders 122 and 132 includeperpendicular regions 122 a and 132 a, but the outer tapers 126 and 136do not include corresponding perpendicular regions. In alternativeembodiments, one or both of the first and second outer tapers 126 and136 may include regions perpendicular to the middle region 110.

Turning now to FIG. 5 , the hollow cylindrical body 101 may comprisebraided or woven wires 160. FIG. 5A is a close-up view of a planarizedversion of the middle region 110 of the stent 100. This close-up viewillustrates the braid pattern, the pitch, and the braid angle α of themiddle region 110. The braid pattern of the middle region 110 (and ofthe entire stent 100) is a one-wire, two-over, two-under braid pattern(referred to as a “one over two” pattern), which means that a singlestrand passes over two strands (or two different portions of itself,such as in a single wire braid design) and then under two other strands(or yet two other portions of itself, such as in a single wire braiddesign). Specifically, a first strand 160 a (or a first length 160 a ofa single strand) passes over a first intersecting strand 160 v (or afirst intersecting length 160 v of a single strand), then passes over asecond intersecting strand 160 w (or a second intersecting length 160 wof a single strand), passes under a third intersecting strand 160 x (ora third intersecting length 160 x of a single strand), and then passesunder a fourth intersecting strand 160 y (or a fourth intersectinglength 160 y of a single strand). The first strand 160 a then repeatsthe pattern with additional strands. An adjacent second strand 160 b (ora second length 160 b of a single strand) offsets the pattern. Startingwith the second intersecting strand 160 w, the second strand 160 bpasses over the second intersecting strand 160 w, passes over the thirdintersecting strand 160 x, passes under the fourth intersecting strand160 y, and then passes under a fifth intersecting strand 160 z. The oneover two pattern may allow for easier elongation of the stent 100. Forexample, during elongation of the stent 100, a one over two pattern mayfacilitate change in the angle of intersection of the wires may asadjacent wires tend to align more with each other during elongation ofthe stent 100 (causing the intersecting wires to come together likescissors closing), which in turn may allow for use with a low-profiledelivery catheter.

Alternative braid patterns may be used as well, such as a one-wire,one-over, one-under braid pattern (referred to as a “one over one”pattern). This braid pattern tends to facilitate stent removal frommandrels. Other possible braid patterns include the diamond two-wire,one-over, one-under braid pattern and the diamond two, two-over,two-under braid pattern.

In some embodiments, the braid pattern may lead to differing cellrequirements over the length of the stent 100. A cell refers to thedesign created by the braid pattern. For example, FIG. 5 illustrates adiamond cell, however, alternative cell designs may be used in the stent100. Thus, depending on stent length and braid pattern, the braiddesigns may result in fractional and non-fractional cell counts. Inother words, a stent may be designed such that a full braid pattern iscompleted on each end of the stent and/or the stent comprises only fullbraid patterns along the length of the sent. Non-fractional cell countsrefer to a whole cell count. For example a stent may have, 20, 30, 40,50, or more full cell counts, or full braid patterns along its length.Fractional cell counts refer to fractional cell count numbers, 20.5,30.5, 40.5, 50.5 or more, meaning the stent has a whole number of fullcell counts in addition to a partial cell (or braid pattern) along thelength of the stent. In some embodiments, the braid pattern may be oneover one and may have a fractional or non-fractional cell count. In someembodiments, the braid pattern may be one over two and may have afractional or non-fractional cell count.

The braid angle a is an angle formed by a given strand of the braided orwoven wires 160, such as the second strand 160 b, relative to thelongitudinal axis 104 of the stent 100, when viewed as illustrated inFIG. 5A. A larger (higher) braid angle, approaching, for example, 90degrees, results in a higher pick count (number of points ofintersection of the strands 160) per given longitudinal length (e.g., aninch) of a given braid (or weaving) pattern. The higher pick count canproduce greater stiffness (i.e., a lower degree of compressibility). Asmaller (lower) braid angle results in a lower pick count per givenlongitudinal length, which can result in greater softness (i.e., lessstiffness and a higher degree of compressibility). For example, in theillustrated embodiments, the braid angle a for the middle region 110 isabout 45 degrees.

The pitch (i.e., lengthwise distance between intersecting strands) alsoimpacts the compressibility and stiffness of the braided or woven wires160. The pitch of the middle region 110 (Pm) is illustrated in FIG. 5Abetween first and second strands 160 a and 160 b. The Pm is governed bythe number of strands interwoven (or interbraided) with each other andthe braid angle α. For example, the Pm may be about 0.75 mm to about2.25 mm for middle region 110 diameters of about 6 mm to about 26 mm.The Pm may be constant, as in the illustrated embodiments. The length ofthe middle region 110 may be any length, such as, for example, about 5mm to about 3 cm.

Referring again to FIG. 5 , the braided or woven wires 160 have auniformly varying pitch along the first inner shoulder 122 (Pi), have auniform pitch at the first crest 124 (Pc), and have a uniformly varyingpitch along the first outer taper 126 (Po). Likewise, in the illustratedembodiment, the braided or woven wires 160 have a correspondinglyuniform varying pitch along the second inner shoulder 132, have acorrespondingly uniform pitch at the second crest 134, and acorrespondingly uniform varying pitch along the second outer taper 136.

In the illustrated embodiments, Pc is less than Pm. In some embodiments,for smaller diameter stents, such as 6 mm and 8 mm stents, the Pc may begreater than Pm. Likewise, in some embodiments, for larger diameterstents, such as 10 mm, 15 mm, and 20 mm stents, the Pc may be less thanPm. For example, the Pc may be about 1.4 mm to about 2.0 mm, such asabout 1.6 mm to about 1.8 mm, which may be more or less than the Pm.

Additionally, in the illustrated embodiments, Pi is continuouslydecreasing from the middle region 110 to the first crest 124. Incontrast, Po is continuously increasing from the first crest 124 to thefirst opening 128. It should be understood that the uniform pitch of Pcrefers to an instantaneous pitch at the first crest 124 governed by thebraid angle β. The instantaneous pitch of Pc does not mean that thebraided or woven wires 160 need to intersect at the first crest 124.Additionally, in the illustrated embodiments, the pitch is increasingdistal to the first crest 124 (the first inner shoulder 122) andincreasing proximal to the first crest 124 (the first outer taper 126).Therefore, there is not a constant pitch as there is for the middleregion 110. However, the instantaneous pitch dictates the theoreticalpitch of intersecting strands if they were laid out in a constant planarfashion, as in FIG. 5A, but utilizing the braid angle β and spacingdictated by the diameter of the first crest 124 and the number ofbraided or woven wires 160 utilized. It is the instantaneous pitch forPc that is uniform as the braided or woven wires 160 cross the firstcrest 124.

Or stated another way, the braid angle continuously increases from theproximal end 112 of the middle region 110 to the first crest 124, andeven though the diameter of the stent 100 is increasing as well, thepitch is continuously decreasing. The instantaneous braid angle β isuniform for all braided or woven wires 160 around the circumference ofthe first crest 124. The braid angle decreases from the first crest 124to the first opening 128, and even though the diameter of the stent 100is decreasing, the pitch continuously increases.

In the illustrated embodiment, the pitch of the braided or woven wires160 at the first opening 128 is greater than the constant pitch Pm ofthe middle region 110. This may facilitate release from the mandrel 200during manufacture. However, it may be desirable to have the Po at theopening 128 (i.e., the braid angle) be as small as possible, while stillallowing for release from the mandrel. For example, the Po may beconfigured to allow the braided or woven wires 160 at the first opening128 to expand almost equal to the diameter of the first crest 124. Itshould be understood that the discussion regarding pitch and braidangles for the first flared end 120 may apply equally to the secondflared end 130.

As discussed above, in some embodiments, Pc may be equal to or greaterthan Pm. In such embodiments, the pitch of Pi may be continuouslyincreasing or stay constant. In such embodiments, the pitch of Po may bedecreasing, stay constant, or be increasing.

In some embodiments, the various pitches allow the stent 100 to beelongated and loaded into a 10.8 French or smaller catheter. It shouldbe understood that the description regarding braid angle and pitches forthe first flared end 120 applies equally to the second flared end 130.

FIG. 5 illustrates a suture line 185 woven through the first end loops129. The suture line 185 may aid with loading of the stent 100 into acatheter and also aid with removal from a patient. The suture line 185may be woven in such a way that pulling it has a “purse string” effecton the first opening 128. Additionally or alternatively, a suture linemay be woven through the second end loops 139. The suture line 185 maybe configured to be permanent or to be removable after the stent 100 isin place in a patient. The suture line 185 may be woven in place after acover 180 (discussed in more detail below) has encapsulated the braidedor woven wires 160, thereby allowing free movement of the suture line185. The ends of the suture line 185 may be secured by a variety ofways, depending on the material of the suture line 185. For example,when the suture line 185 is made of a fiber, such as Teleflex ForceFiber, then the ends of the suture line 185 may be secured via a knot,adhesives, or a combination thereof. In another example, when the sutureline 185 comprises a metal cable, then the ends may be secured viacrimping, a metal band, or combinations thereof.

The braided or woven wires 160 may be braided or woven in a givenpattern in accordance with an appropriate braid design, such as aclosed-loop braid design, a single wire woven design, an endless braiddesign, or the like. The stent 100 of the illustrated embodiments isconfigured as a closed-loop braid design in which multiple strands areinterlaced in a first direction (e.g., a distal direction) and then turnand are interlaced back in an opposite second direction (e.g., back inthe proximal direction). The closed-loop braid design allows for fullyautomated or partially automated braiding (e.g., interlacing) of themultiple strands. In other embodiments, the stent 100 may be configuredas a single wire woven design in which a single strand is woven (e.g.,interlaced) with itself. It should be understood that when woven wires160 are referenced herein that the ends of a single strand will overlapwith itself. In still other embodiments, the stent 100 may have anendless braid design in which multiple strands are interlaced,generated, for example, by an automated process braiding in a singledirection. An endless braid design may involve a braiding process thatinterlaces strands from one end to the other (e.g., does not involve aturn and return in the opposite direction). The endless braid design mayinvolve more welds than the closed-loop braid design. A skilled artisanhaving the benefit of this disclosure can appreciate that a stent orimplantable prosthesis of the present disclosure may have a constructionof any of a single wire woven design, an endless braid design, or aclosed-loop design and that such construction may utilize any suitablebraid pattern.

The braided or woven wires 160 may include varying numbers of strands.For example, a smaller diameter stent, such as a 6 mm (based on themiddle region 110 diameter), may include 24 strands (12 wires if aclosed-loop braid design) and a larger diameter stent, such as a 20 mm,may include 64 strands (32 wires if a closed-loop braid design).

When braided or woven in a closed-loop braid design, the braided orwoven wires 160 may start and stop at various locations on the stent100. For example, individual braided wires 160 may be braided startingfrom the second flared end 130, through the middle region 110, throughthe first flared end 120, to the first opening 128, back through thefirst flared end 120, back through the middle region 110, and backthrough the second flared end 130. In other embodiments, the braided orwoven wires 160 may start in the middle region 110.

FIG. 6 illustrates such an example where the beginning and the end ofeach of the individual braided wires 160 overlap with other individualbraided wires 160 underneath an intersecting strand along the secondouter taper 136 and not at the second opening 138. For example, thesecond strand 160 b is illustrated as bent about 90 degrees and thenintersecting the first strand 160 a. The interior region of the bentsecond strand 160 b defines a second end loop 139 and the exteriordefines a portion of the second opening 138.

FIG. 6 illustrates the use of spot welds 170 to secure each strand toanother strand, such as the first strand 160 a′ to another strand 160a″. In this embodiment, the overlap extends to either side of theintersection underneath the third intersecting strand 160 x and the spotwelds 170 a and 170 b are on either side the intersection. Otheralternatives include increasing the length of the overlap and placingspot weld 170 b on an opposing side of a second intersecting strand,such as the fourth intersecting strand 160 y. Alternatively, the tensionof the braid pattern may be used to secure the first strand 160 a toitself, without spot welds 170. For example, as illustrated, a stub end160 b′ of the bent second strand 160 b resides on the interior of thejoint with a long end 160 b″ of another strand. The tension of the jointhelps hold the stub end 160 b′ in place. Moreover, the ends of thestands may be inserted into a sleeve and then the sleeve crimped (notshown). One of ordinary skill in the art, with the benefit of thisdisclosure, would understand that a variety of termination strategiesmay be used to secure the first strand 160 a to itself (and likewise forsecuring two separate strands together). Securing the ends of the stands160 to each other at a location other than the first and second openings128 and 138 decreases strain on the joint, as compared, for example, towelding the ends to each other to form the second end loop 139. However,in some embodiments, the ends of the strands 160 may be welded to eachother to form the first and second end loops 129 and 139.

FIG. 6A illustrates an embodiment of the braided or woven wires 160starting and terminating in the middle region 110. Embodiments whereinthe strand ends terminate anywhere within the middle region 110 and nostrand ends are disposed within the first flared end 120 and the secondflared end 130 are within the scope of this disclosure. The terminationstrategies discussed above with respect to terminating wires at thefirst and second outer tapers 126 and 136 apply to this embodiment aswell.

FIG. 6 further illustrates a radiopaque coil 172 slid over the secondstrand 160 b between the bend and the intersection with the first strand160 a. The radiopaque coil 172 may be locked in place by the bend andthe intersection. The radiopaque coil 172 may also be placed in otherlocations, such as at the bend. The radiopaque coil 172 may comprise atightly wound wire, such as a 25 micron wire. The wire may compriseplatinum and tungsten or other radiopaque materials, such as platinumand iridium. The radiopaque coil 172 may be evenly spaced on the secondend loops 139 circumscribing the second opening 138 and likewise for thefirst end loops 129 (see FIG. 7 ). A few of the radiopaque coils 172 mayalso be placed in the middle region 110. A number of alternatives to theradiopaque coils 172 exist, for example, the braided or woven wires 160(or only a few of them) may be made of a radiopaque material, such asDFT wire with a nickel-titanium sheath with a platinum core.

The first end loops 129 may uniformly peak at the first end plane 127(see FIGS. 2 and 5 ) and the second end loops 139 uniformly peak at thesecond end plane 137 (see FIGS. 3 and 5 ). Alternatively, the first andsecond end loops 129 and 139 may be staggered, such as illustrated inFIG. 7 for the first end loops 129″ of the stent 100″. It should beunderstood that the disclosure regarding the stent 100 applies equallyto the stent 100″ and vice versa.

The braided or woven wires 160 forming the stent 100 may comprise anysuitable material known in the art, including plastics and memoryalloys. In some embodiments, the braided or woven wires 160 may beNitinol, including ASTM F2063. In one embodiment, the thickness of amemory alloy strand of the braided or woven wires 160 may be about 0.003in. to about 0.009 in. In other embodiments, the thickness may be about0.005 in. to about 0.065 in., such as for about 6 mm to about 20 mm indiameter (middle region 110) stents. Generally speaking, smaller wiresmay be used with smaller diameter stents and larger diameter wires maybe used with larger diameter stents.

FIG. 7 illustrates that the stent 100″ further includes a cover 180″coupled to the braided or woven wires 160″. The cover 180″ can furtherdefine the interior dimension 102″ and the outer dimension 103″. Thecover 180″ may be elastomeric, polymeric, or comprised of any othermaterial known in the art. In some embodiments, the cover may includesilicone, while in certain embodiments the cover may be comprised onlyof silicone, such as Nusil MED-4055 for short-term implants or MED-4755for long-term implants. 55 durometer and higher silicones may facilitatecrimping into low-profile catheters, such as a 10.8 French sizedcatheter.

In some embodiments, the cover 180 (see FIG. 5 ) may be applied suchthat it tends to ebb and flow into spaces between portions of thebraided or woven wires 160, resulting in a “tire tread” like outersurface, rather than a smooth outer cover. In some embodiments such adesign may be configured to allow tissue to lock into the uneven spacesand treads, thus adding anti-migration properties in some instances.

In some embodiments the cover 180 may include multiple subparts orlayers. For example, in some embodiments the cover 180 may be a two-partdesign. Such two-part covers may be composed of a base cover whichencapsulates the braided or woven wires 160 and a second cover which maybe applied after the first cover cures. In certain embodiments, thesecond cover may only be applied to the outside diameter of the stent100 and may chemically bond to the first cover layer. Multiple-layeredcovers may be configured such that the primary layer adds elasticity orresiliency to the stent while the second, outer layer reduces frictionalong the outside diameter. Manufacturing aids, such as MED-400silicone, may be present as well. Manufacturing aids may help withcrimping and loading, reduce deployment force, and increase the shelflife of the stent 100. It is within the scope of this disclosure to useany of the exemplary materials for any of the layers.

In FIG. 7 , the cover 180″ extends beyond the first end loops 129″,further narrowing the circumference of the first opening 128″. In suchembodiments, the cover 180″ may extend about 0.2 mm to about 1 mm beyondthe wires.

Regarding manufacturing of the stent 100, initially, a first mandrel(not shown) may be used. The first mandrel may have an outer cylindricalsurface with a constant cylindrical shape and have a diameter equal tothe diameter of the middle region 110 of the stent 100. The braided orwoven wires 160 (when they constitute a shape-memory material) may bebraided or woven so as to have a first end region, a middle region, anda second end region along the first mandrel. The middle region may havea constant pitch and the first and second end regions may havecontinuously varying pitches.

FIG. 5B illustrates an example of the various pitches that may bebraided or woven onto the first mandrel to achieve the pitches of thestent 100 when the stent 100 is stretched into final form. FIG. 5Billustrates continuous wires 300 that may be used for providing thebraided or woven wires 160. Starting from the middle, region 310corresponds to middle region 110 of the stent 100. Region 322corresponds to the first inner shoulder 122 of the stent 100. Region 332corresponds to the second inner shoulder 132 of the stent 100. Region326 corresponds to the first outer taper 126 of the stent 100. Region336 corresponds to the second outer taper 136 of the stent 100.Likewise, line 312 corresponds to the proximal end 112 of the middleregion 110 and line 313 corresponds to the distal end 113. Line 324corresponds to the first crest 124 and line 334 corresponds to thesecond crest 134. Line 328 corresponds to the first opening 128 and line338 corresponds to the second opening 138. Regions 300 a and 300 bfacilitate manufacturing and separate one set of braided or woven wires160 from a second set of braided or woven wires 160.

When braided or woven onto the first mandrel, the Pm may be constant andmay be the same as it will be in the stent 100; however, the Pi, Pc, andPo are not. The Pc is greater than the Pi and Po, which are both greaterthan the Pm. Once formed into the stent 100, the Pc will be less thanthe Pm, as discussed previously.

FIG. 8 illustrates a second mandrel 200 for use in manufacturing thestent 100. The second mandrel 200, when assembled, matches the shape ofthe stent 100. The second mandrel 200 includes two parts, a first end200 a and a second end 200 b. The second mandrel 200, when assembled,includes a middle cylindrical region 210 that matches the diameter ofthe middle region 110 of the stent 100. Likewise, the first part 200 aincludes a first flared end 220 that matches the shape of the firstflared end 120. The second part 200 b includes a second flared end 230that matches the shape of the second flared end 130. The second part 200b includes a plug 201 for insertion into a receiver 202 of the firstpart 200 a. One of skill in the art, with the benefit of thisdisclosure, would understand that a variety of structures and approachesmay be used to connect the first part 200 a to the second part 200 b.

A set of braided or woven wires 160 is cut in the regions 300 a and 300b to separate it from the continuous wires 300. The braided or wovenwires 160 may then be removed from the first mandrel. The first andsecond parts 200 a and 200 b may be slid into the braided or woven wires160 until the first and second parts 200 a and 200 b are joinedtogether. Regions 310, 322, 326, 332 and 336 may then be aligned overthe middle region 210, the first flared end 220, and the second flaredend 230 of the second mandrel 200. The pitches of Pi, Pc, and Po changeas the braided or woven wires 160 are slid in place over the secondmandrel 200. The braided or woven wires 160 are then set in place, suchas with heat.

After being heat-set, for example, the braided or woven wires 160 may beremoved from the second mandrel 200. The second mandrel 200 may beseparated into two parts and removed from inside the stent 100. The Popitch allows the braided or woven wires 160 to scissor sufficient toallow removal of from the first and second parts of the second mandrel200 without damage.

The braided or woven wires 160 may then be placed on a third mandrelthat is the same shape as the mandrel 200 for coating. The third mandrelmay be polished to thereby leave a surface roughness on the cover 180equal to or less than 2 Ra (arithmetic average of roughness profile). Aswith the second mandrel 200, the Po pitch allows the braided or wovenwires 160 to scissor sufficient to allow removal of from the first andsecond parts of the third mandrel without damage.

The stents disclosed herein, such as the stent 100, may be used fordraining one lumen of a patient into another lumen of a patient, suchas, for example, transgastric or transduodenal drainage of a pancreaticpseudocyst, of a biliary tract, of a gallbladder. An access port may becreated between a first lumen of the patient and a second lumen of thepatient. For examples, NOTES (natural orifice transluminal endoscopicsurgery) may be used to create the access port between the lumens. Thefirst lumen may be the gastrointestinal tract (for example, theesophagus, stomach, pylorus, or bowel) of the patient. The second lumenmay be the gallbladder, a pancreatic cyst, a biliary tract, or someother lumen that needs drainage. A delivery catheter with the stentloaded in an elongated and stretched state may be introduced through theworking channel of an echoendoscope or other device. The second flaredend (in its stretched and elongated state) may be introduced through theaccess port into the second lumen and then the second flared endreleased so that the second flared end is secured against a luminal wallof the second lumen. The first flared end can then be released so thatthe first flared end is secured against a luminal wall of the firstlumen. In its unstretched and unelongated state, the interior dimensionof the stent provides fluidic communication between the first and secondlumens. The second lumen can passively drain into the first lumen or thesecond lumen can be actively drained by insertion of other tools throughthe interior dimension into the second lumen to remove material from thesecond lumen (such as, for example, gallstones or malignant or necrotictissue).

Any methods disclosed herein include one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.Moreover, only a portion of a method described herein may be a separatemethod. Stated otherwise, some methods may include only a portion of thesteps described in a more detailed method.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. It will be apparent to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of this disclosure.

1-20. (canceled)
 21. A stent comprising: a hollow cylindrical bodyhaving an interior dimension and an exterior dimension and comprising amiddle region that extends to a first flared end and also extends to anopposing second flared end, the first flared end comprising a firstinner shoulder, a first crest, a first outer taper, and a first opening,wherein the first inner shoulder extends from one end of the middleregion to the first crest, wherein a diameter of the first crest isgreater than a diameter of the middle region, wherein the first outertaper extends from the first crest to the first opening, wherein thefirst opening provides a first boundary between the interior dimensionand the exterior dimension, the hollow cylindrical body characterized bya longitudinal plane that bisects the hollow cylindrical body along itslongitudinal axis, characterized by a first perpendicular plane thatencompasses a circle defined by the first crest, and wherein the firstperpendicular plane is perpendicular to the longitudinal plane, whereina profile of at least a portion of the first inner shoulder, the firstcrest, and at least a portion of the first outer taper circumscribes aportion of a first elliptical arc that lies in the longitudinal plane,wherein the first elliptical arc includes an upper antipodal point ofthe first ellipse, wherein a lower antipodal point of the first ellipseis outwardly offset along the longitudinal plane relative to the firstperpendicular plane and the middle region.
 22. The stent of claim 21,wherein the second flared end comprises a second inner shoulder, asecond crest, a second outer taper, and a second opening, wherein thesecond inner shoulder extends from one end of the middle region to thesecond crest, wherein a diameter of the second crest is greater than adiameter of the middle region, wherein the second outer taper extendsfrom the second crest to the second opening, wherein the second openingprovides a second boundary between the interior dimension and theexterior dimension,
 23. The stent of claim 22, wherein the hollowcylindrical body is further characterized by a second perpendicularplane that encompasses a circle defined by the second crest, the secondperpendicular plane also perpendicular to the longitudinal plane, andwherein a profile of at least a portion of the second inner shoulder,the second crest, and at least a portion of the second outer tapercircumscribes a portion of a second elliptical arc of a second ellipsethat lies in the longitudinal plane, wherein the second elliptical arcincludes an upper antipodal point of the second ellipse, wherein a lowerantipodal point of the second ellipse is outwardly offset along thelongitudinal plane relative to the second perpendicular plane and themiddle region.
 24. The stent of claim 21, wherein a diameter of thefirst opening is greater than the diameter of the middle region, butless than the diameter of the first crest.
 25. The stent of claim 21,wherein the hollow cylindrical body comprises braided or woven wireshaving a uniformly varying pitch along the first inner shoulder that iscontinuously decreasing from the middle region to the first crest. 26.The stent of claim 21, wherein the hollow cylindrical body comprisesbraided or woven wires having a uniformly varying pitch along the firstouter taper that is continuously increasing from the first crest to thefirst opening.
 27. The stent of claim 21, wherein the lower antipodalpoint of the first ellipse is outwardly offset along the longitudinalplane relative to the first perpendicular plane and the middle region byabout 5 degrees to about 60 degrees.
 28. The stent of claim 21, whereinthe first outer taper comprises a suture line that surrounds the firstopening, wherein the suture line is configured to facilitate stretchingand elongation of the hollow cylindrical body when the suture line ispulled in the direction of the longitudinal axis and outwardly away fromthe first perpendicular plane.
 29. The stent of claim 21, wherein thebraided or woven wires comprise a uniformly varying pitch along thefirst outer taper that is configured to allow the braided or woven wiresat the first opening to expand equal to the diameter of the first crest.30. A stent comprising: a hollow cylindrical body having an interiordimension and an exterior dimension and comprising a middle region thatextends to a first flared end and also extends to an opposing secondflared end, the first flared end comprising a first inner shoulder, afirst crest, a first outer taper, and a first opening, wherein the firstinner shoulder extends from one end of the middle region to the firstcrest, wherein a diameter of the first crest is greater than a diameterof the middle region, wherein the first outer taper extends from thefirst crest to the first opening, wherein a diameter of the firstopening is greater than the diameter of the middle region but less thanthe diameter of the first crest, and wherein the first opening providesa first boundary between the interior dimension and the exteriordimension, the second flared end comprising a second inner shoulder, asecond crest, a second outer taper, and a second opening, wherein thesecond inner shoulder extends from one end of the middle region to thesecond crest, wherein a diameter of the second crest is greater than adiameter of the middle region, wherein the second outer taper extendsfrom the second crest to the second opening, wherein a diameter of thesecond opening is greater than the diameter of the middle region butless than the diameter of the second crest, and wherein the secondopening provides a second boundary between the interior dimension andthe exterior dimension, wherein a profile of at least a portion of thefirst inner shoulder, the first crest, and at least a portion of thefirst outer taper circumscribes a portion of a first arc that lies inthe longitudinal plane, and wherein a profile of at least a portion ofthe second inner shoulder, the second crest, and at least a portion ofthe second outer taper circumscribes a portion of a second arc that liesin the longitudinal plane.
 31. The stent of claim 30, wherein the hollowcylindrical body comprises braided or woven wires having a constantpitch along a length of the middle region, the braided or woven wireshaving a uniformly varying pitch along the first inner shoulder, thebraided or woven wires having a constant pitch at the first crest, thebraided or woven wires having a uniformly varying pitch along the firstouter taper, the braided or woven wires having a uniformly varying pitchalong the second inner shoulder, the braided or woven wires having aconstant pitch at the second crest, and the braided or woven wireshaving a uniformly varying pitch along the second outer taper.
 32. Thestent of claim 31, wherein the uniformly varying pitch along the firstand second inner shoulders is continuously decreasing from the middleregion to the first and second crests, respectively.
 33. The stent ofclaim 31, wherein the uniformly varying pitch along the first outertaper is continuously increasing from the first crest to the firstopening and wherein the uniformly varying pitch along the second outertaper is continuously increasing from the second crest to the secondopening.
 34. The stent of claim 31, wherein the uniformly varying pitchalong the first outer taper is configured to allow the braided or wovenwires at the first opening to expand equal to the diameter of the firstcrest and wherein the uniformly varying pitch along the second outertaper is configured to allow the braided or woven wires at the secondopening to expand equal to the diameter of the second crest.
 35. Thestent of claim 31, wherein individual braided or woven wires are braidedor woven starting from the second flared end, through the middle region,through the first flared end, to the first opening, back through thefirst flared end, back through the middle region, and back through thesecond flared end.
 36. The stent of claim 35, wherein for braided wiresa beginning and an end of each of the individual braided wires overlapwith each other or a different wire end underneath a crossover wirealong the second outer taper and not at the second opening of the secondflared end, and wherein for woven wires a beginning and an end of eachof the individual woven wires overlap with each other underneath acrossover wire along the second outer taper and not at the secondopening of the second flared end.
 37. The stent of claim 35, wherein forbraided wires a beginning and an end of each of the individual braidedwires overlap with each other or a different wire end underneath acrossover wire along the middle region, and wherein for woven wires abeginning and an end of each of the individual woven wires overlap witheach other underneath a crossover wire along the middle region.
 38. Amethod of making a stent, the method comprising: providing a firstmandrel having an outer cylindrical surface with a constant cylindricalshape and having a diameter equal to the diameter of a desired middleregion of a stent; and braiding or weaving wire comprised ofshape-memory material around the outer cylindrical surface of the firstmandrel to form braided or woven wires of the stent, wherein the braidedor woven wires have a first end region, a middle region, and a secondend region, wherein the middle region comprises a constant pitch and thefirst and second end regions have continuously varying pitches.
 39. Themethod of claim 38, further comprising: providing a second mandrelhaving a shape similar to a desired shape of the stent when the stent isin an unstretched and unelongated state, wherein the second mandrelcomprises a middle cylindrical region, a first flared end, and a secondflared end, wherein a diameter of the middle cylindrical region matchesthe diameter of the outer cylindrical surface of the first mandrel, andwherein a first crest of the first flared end and a second crest of thesecond flared end each have a diameter greater than the diameter of themiddle cylindrical region; removing the braided or woven wire from thefirst mandrel; placing the braided or woven wire over the second mandrelso that the first end region aligns with the first flared end of thesecond mandrel, the middle region aligns with the middle cylindricalregion of the second mandrel, and the second end region aligns with thesecond flared end of the second mandrel; and heat-setting the braided orwoven wires.
 40. The method of claim 39, further comprising: removingthe braided or woven wire from the second mandrel; providing a thirdmandrel having a shape similar to the second mandrel; placing thebraided or woven wire over the third mandrel; and coating the braided orwoven wire.